2020-ESMO-胃癌免疫治疗研究进展 (1).pptx

2020 ESMO 胃癌免疫治疗研究进展不同疾病阶段胃癌免疫治疗关键临床研究概览Nivo + IPI vs Nivo + 化疗 vs 化疗，CM-649 Ⅲ期(全球)2020 ESMO公布阳性结果Nivo+SOX/CapeOXATTRACTION-04 Ⅲ期 (亚洲)2020 ESMO公布阳性结果Nivo 单药ATTRACTION-02Ⅲ期 (亚洲)一线化疗后Avelumab 单药维持 vs继续化疗或BSC JAVELIN Gatric 100, Ⅲ期(全球)完成的研究阴性Pembro 单药，PD-L1+KN-059, Ⅱ期 (全球)Pembro vs TAX, PD-L1+KN-061, Ⅲ期(全球)Pembro 单药 或Pembro + 化疗 KN-062, Ⅲ期(全球)联合化疗阴性阴性转移性疾病早期疾病一线治疗辅助/围术期二线治疗三线治疗Pembro + 化疗 vs 安慰剂+化疗KN-859, Ⅲ期(全球)Nivo+化疗 vs 安慰剂+化疗ATTRACTION-5 (ONO 38) Ⅲ期(亚洲) 辅助免疫治疗相关的临床研究正在从三线向一线，以及围术期靠拢。Pembro + 靶向 vs 靶向 HER-2 +KN-811, Ⅲ期(全球)正在进行的研究Pembro + 化疗 vs安慰剂+化疗KN-585, Ⅲ期 (全球) 围术期Sintilimab+化疗 vs 化疗NC Ⅲ期(中国)目录3L+治疗：夯实数据2L+治疗：持续探索1L治疗：新的突破免疫+化疗：CheckMate 649 LBA6 ATTRACTION-4 396O免疫+抗血管生成：LEAP-005 LBA41免疫单药：日本人群真实世界数据 1444PCheckMate 649（全球研究）：纳武利尤单抗+化疗 VS 化疗一线治疗晚期或转移性胃癌/胃食管结合部癌/食管腺癌CheckMate 649 是一项随机，开放标签, III期研究双终点: OS and PFSg (PD-L1 CPS ≥5)次要研究终点: OS (PD-L1 CPS ≥ 1 or 全部随机患者) OS (PD-L1 CPS ≥ 10)PFSg (PD-L1 CPS ≥ 10, 1, or 全部随机人群) ORRgR1:1:1c关键入组标准：年龄 ≥ 18 岁不可切除的进展期或复发胃/胃食管交界处癌/食管腺癌既往未经系统治疗包括HER2靶向治疗等作为初始治疗可检测肿瘤组织标本 ≤6个月ECOG PS (0 vs 1)分层因素：TPS表达(≥ 1% vs < 1%b)地区 (亚洲 vs 美国/加拿大 vs ROW)ECOG PS (0 vs 1)化疗方案 (XELOX vs FOLFOX)n =789NIVO1 + IPI3 Q3W × 4 then NIVO 240 mg Q2WdNIVO 360 mg + XELOXe Q3Wd or NIVO 240 mg + FOLFOXf Q2Wdn =792N = 1581, including 955 patients (60%) with PD-L1 CPS ≥ 5XELOXe Q3Wdor FOLFOXf Q2Wd 数据截止日(2020年5月27日), 中位随访时间 12.1 个月haClinicalTrials.gov number, NC b< 1% includes indeterminate tumor cell PD-L1 expression; determined by PD-L1 IHC 28-8 pharmDX assay (Dako); cAfter NIVO + chemo arm was added and before new patient enrollment in the NIVO1+IPI3 group was closed; dUntil documented disease progression (unless consented to treatment beyond progression for NIVO + chemo), discontinuation due to toxicity, withdrawal of consent, or study end. NIVO is given for a maximum of 2 years; eOxaliplatin 130 mg/m2 IV (day 1) and capecitabine 1000 mg/m2 orally twice daily (days 1–14); fOxaliplatin 85 mg/m2, leucovorin 400 mg/m2, and FU 400 mg/m2 IV